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On the eve of the World Health Assembly, the permanent mission of Brazil organised an informal meeting on sanitary regulation and how to improve cooperation among drug regulatory agencies. Major stakeholders were invited to present challenges and ongoing efforts to improve global quality, safety and efficacy of medical products.

The 18 May meeting was meant to bring together various actors, among which were a number of national drug regulatory agencies, to address main concerns preventing access to safe, efficient and affordable medicines to all people in the context of a globalised world.

Amb. Maria Nazareth Farani Azevêdo, the Brazilian ambassador to the United Nations in Geneva, said the seminar was set to be a collective reflection on how to improve cooperation among national authorities.

“The main responsibility of national regulatory agencies is the protection of human health against potential risks by a variety of products in circulation in a globalised world,” she said, but added that while ensuring safety, unnecessary obstacles to the availability and access of these same products should be avoided.

WHO Director Supportive Of Health Regulators

World Health Organization Director General Margaret Chan, at the close of the meeting, championed the cause of health regulatory authorities. “I am one of you,” she said. “Before I joined WHO, I worked in Hong Kong. I have been a drug and food regulator for almost ten years … so I know your business very well, I know your challenges and I also know your strength,” she said.

Regulation is one of the most important public health prevention tools, she said, but “regulatory control of medicines has become a complex task in a world of radically increased interdependence characterised by a phenomenal growth in both the volume of international trade and the number of players.”

No country can deal alone with the complexity, Chan said, “no matter how wealthy,” citing the United States. The regulators’ mission is also complicated by “the use of internet sale of medical products and the very sophisticated tactics used by organised crime” who provide Substandard/Spurious/Falsely-Labelled/Falsified/Counterfeit products, she said, using the terminology adopted by WHO members after long negotiations to describe substandard medicines.

Chan said she supported the strengthening of regulatory authorities in her personal capacity, as this support was subject to agreement by WHO member states. “What is the use of prequalification done by WHO if the regulatory authorities in the country do not have the capacities, the means and the resources to exercise their function?” she asked.

Chan also expressed concern that many countries do not regulate medical products for export while some countries regulate imports but not local production. “In this day and age, if a government has double standards, one standard for its people and another standard for making money, you would better be careful, because information is very powerful and accountability to your people is important,” she said.

On the WHO prequalification programme, Chan said one of its results was to give the opportunity for manufacturers from low- and middle-income countries to enter the market with straight quality and safety standards, and to enter into fair competition with other manufacturers, in order to reduce the price to improve access to medicine to the poor people.

“If you would like products made in your countries to be pre-qualified by WHO, especially vaccines, you need to be a functional national regulatory authority in the first place,” she said. “Drug regulatory authorities often do not have the resources they need and sometimes do not have the support they require to do their job properly.”

Challenges for Regulatory Agencies

Three sessions punctuated the meeting. The first session chaired by Michel Sibidé, executive director of the Joint UN Programme on HIV/AIDS (UNAIDS), addressed challenges in ensuring the safety of products in a globalised world.

Disparities in capacities and resources among different regulatory agencies were pointed out by several speakers, such as Nathalie Wourgaft, medical director of the Drugs for Neglected Diseases initiative.

Denis Broun, executive director of UNITAID, said the organisation supports mechanisms for homologation so that people can register their products and make them available in markets. Very often for products oriented toward the markets in poor countries it can take five years to ten years between the time the product is ready and the time it enters the market, he said.

He praised the WHO prequalification mechanism, which he said was supported mainly by UNITAID, due to the funding shortage at WHO. “We consider this of one of our best investments with a major market impact and a major public health impact,” he said.

Elodie Jambert, Médecins Sans Frontières (MSF) international pharmacist coordinator, said the quality of medicines available in developing countries remains highly variable, with problems such as sub-dosage, poor stability, lack of sterility, and the presence of impurities.

MSF meets a number of constraints for importation of medicines, for example, different requirements for importation according to national regulatory agencies, legislative rules that are not always clear, some importations blocked from specific countries of origin, and political pressure to use locally produced medicines.

Challenges with local purchases include the risk of purchasing medicines of unknown quality, and the lack of traceability of the origin of the medicine, Jambert said. MSF supports regional cooperation between regulatory agencies, she said, adding that WHO should continue the development of norms and standards for phamacovigilence and support their implementation at country level.

Marie-Pierre Poirier, regional director for the United Nations Children’s Fund (UNICEF), said the organisation is facing many problems with the quality of medical products. In particular, she said, many manufacturers continue to produce poor quality products. This situation is mainly due to the fact that “many exporting countries do not control the quality of products they export, [and] national regulatory agencies of some low- and middle-income countries are inadequately resourced and do not manage to control the quality of products that are domestically produced,” she said. Also, many national procurement agencies “continue to purchase the cheapest products irrespective of the quality unless they are prevented to do so by the national regulators,” she said.

International Initiatives

The second panel focused on international initiatives and cooperation to promote access and ensure quality, safety and efficacy of products. It was chaired by Carissa Etienne, assistant director general for health systems and services at WHO.

James Fitzgerald, senior advisor on Medicines and Health Technologies for the Pan American Health Organization (PAHO)introduced the work of PAHO, and Anne Hayes, inspection manager for the intergovernmental Pharmaceutical Inspection Co-operation Scheme (PIC/S) presented the goals and achievements of the PIC/S. One of the core principles of the scheme is the development of quality systems and the training of inspectors, as well as the promotion of harmonised good manufacturing practices (GMP) standards.

Market control and supply chain security remains outstanding issues in many countries, said Lembit Rago, coordinator, Quality Assurance and Safety Medicines Essential Medicines and Health Products for WHO. In spite of progress in developing regulatory capacities, the gap between well resourced and less resourced regulators may have even increased, he said. WHO, he said, has developed a comprehensive assessment tool for medicines regulatory authorities.

“Not a single regulator today can work meaningfully in isolation,” he said, and not use other regulators’ experience, knowledge and information. “The future of medicines regulations is more in harmonisation, collaboration and network.”

The third session was aimed at challenges and initiatives of regional regulatory authorities, chaired by Azevêdo, and panellists discussed the challenges in their jobs.

Margaret Hamburg, commissioner for the US Food and Drug Administration, said for many years medicines in the US were produced within the US borders but in recent times, FDA regulated products that originated from some 150 countries.

In this context of global sources of production, the “FDA can no longer remain a domestically focused agency reacting to a globalised world. Instead, we must transform into a proactive and global public health agency,” she said.

In April, she said, the FDA released a report on the FDA global cooperation for product safety. In the report, she said, “we describe the FDA’s commitment to partner with our foreign counterparts in global coalitions ” of regulators dedicated to building and strengthening a product safety net around the world.

Guido Rasi, executive director of the European Medicines Agency, said the complexity of processes is increasing, with more complex supply chains, and an increasing scope for counterfeit products. He called for identifying synergies before launching new initiatives in order to avoid duplication. The European Union supports efforts to improve international cooperation amongst regulatory authorities of medicinal products, he said.

D.N. Singh, deputy at the Drugs Controller General of India, said challenges are mainly the harmonisation of regulatory systems and standards of medicines, the exchange and sharing of information, and the accessibility and affordability of quality drugs.

With nine ambassadors, 22 health authorities, 16 organisations from civil society and nine industrial associations present, Dirceu Brás Barbano, director chairman of the Brazilian National Health Surveillance Agency, said a consensus had been identified during the meeting. That is, there is a necessity and the possibility to do more in the field of cooperation, and a desire to build mutual confidence and trust among regulatory authorities.